The National Health Council (NHC) appreciates the opportunity to provide comments on the Food and Drug Administration’s (FDA’s) draft guidance on Enhancing the Diversity of Clinical Trial Populations. While industry […]
FDA regulations
Webinar Preview: Perspectives on the FDA’s 2nd Patient-Focused Drug Development Guidance
By Maddie Mason, Associate, Policy On Friday, Dec. 13 from 2 – 3 p.m. ET/ 11 a.m. – noon PT, the National Health Council (NHC) and our member organizations will […]
FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials
By Elisabeth M. Oehrlein, PhD, MS, Senior Director, Research and Programs Patient-centered research and care focuses on outcomes that are most important to patients, which often are about how they […]
Recent NHC Comments Submitted to FDA & CMS
By Eric Gascho, NHC Vice President of Policy and Government Affairs The National Health Council frequently submits letters and comments on the administration’s rules and actions when its subjects are […]
Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses
The National Health Council (NHC) appreciates the opportunity to respond to the Centers for Medicare & Medicaid Services’ (CMS’) Proposed Rule entitled “Modernizing Part D and Medicare Advantage to Lower […]
Patient Engagement in Medical Device Clinical Trials Discussion Document
The National Health Council (NHC) is pleased to provide comments on the Food and Drug Administration (FDA)’s solicitation for feedback on patient engagement in medical device clinical trials, including the […]
The NHC’s Policymaking Process
By Eric Gascho, Vice President, Policy & Government Affairs The National Health Council (NHC) has a member-driven policy development process, which was just completed for 2019. Our patient advocate members […]
FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials
FDA’s Roadmap to Patient-Focused Outcome Measurement in Clinical Trials This webinar featured Laurie Burke, MPH, Founder of the LORA Group, LLC introduced participants to a document, the Roadmap, developed by […]
FDA Standard Core Clinical Outcome Assessments and Endpoints
The NHC supports the FDA’s interest in promoting the “development of publicly available, standard core sets of Clinical Outcome Assessment (COA) measures for specific disease indications.” We appreciate the amount […]
Elevating and Improving Patient-Focused Drug Development
By Jason Harris, NHC Associate Director, Policy and Programs The driving force behind all of our work at the National Health Council (NHC) is meaningfully engaging patients in every aspect […]